MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. DONORSCREEN-HLA CLASS I AND CLASS II

Catalog Number	DSI+II
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2016 customer contacted technical support with a complaint (b)(4) for donor screen (dsi+ii) lot 3003895ab.They stated that they had conducted a small study consisting of 284 never pregnant/transfused female donors.The results from that study resulted in 14% of those donors being positive for hla class i and 74% being positive for hla class ii.The customer also stated that they were experiencing a higher than expected reactivity rate of 24.7%.The customer also stated that the results for 3462 samples had been reported from september 28, 2016 through october 13, 2016.The customer performed the testing per the donor screen ifu (303456.Ifuen, rev.F) and the results were valid.The root cause of the unexpected increase in reactivity rate is unknown.Immucor makes no claims on the reactivity rates within the donor screen population of donors.Per the ifu, the presence of immune complexes or other immunoglobulin aggregates in the sample may cause an increased non-specific binding and produce false-positive results in the assay.The issue is sample dependent.There was no reported harm to the patients.

• Brand Name: DONORSCREEN-HLA CLASS I AND CLASS II
• Common Device Name: DONORSCREEN-HLA CLASS I AND CLASS II
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7714605
• Report Number: 2183608-2018-00015
• Device Sequence Number: 11200990
• Product Code: MZI
• UDI-Device Identifier: 10888234500193
• UDI-Public: 10888234500193
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: BK070045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/15/2018
• Device Catalogue Number: DSI+II
• Device Lot Number: 3003895AB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1